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871589

Carter BloodCare — FEI 3003830999

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 17, 2014
Fiscal Year
2014
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Woodway, TX (United States)

Facility

Other inspections at this facility

  • 1227222 (NAI Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1088131 (NAI Fri Apr 05 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029042 (NAI Wed Aug 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 775769 (NAI Thu Apr 05 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 620063 (VAI Thu Oct 15 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
20821 CFR 640.3(a)(1)Donor suitability procedures not followed
4121 CFR 606.40(a)(1)Provide space for examination
904421 CFR 600.10(b)Personnel capabilities
905221 CFR 600.11(b)Equipment
9121 CFR 606.100(b)(12)Criteria for suitability of reissue of returned blood
9821 CFR 606.100(c)Thorough investigations